SBIR Phase II definition

SBIR Phase II means the grant stage provided by the Act for extension of the results of an SBIR Phase I project for the purpose of developing an idea into a commercially useful product or process. “Small business” means a private entity having 250 or fewer employees and which is organized for
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Examples of SBIR Phase II in a sentence

  • As prescribed in 1819.7302(b), insert the following clause: Limitation on Subcontracting - SBIR Phase II Program (OCT 2006) The Contractor shall perform a minimum of one-half of the research and/or analytical effort (total contract price less profit) conducted under this contract.

  • A small business may receive no more than two SBIR Phase II awards for the same R&D project, and the awards must be made sequentially.

  • For SBIR Phase II Contracts : Select "one half" from the drop down box.

  • A succinct commercialization plan must be in- cluded in each SBIR Phase II proposal moving toward commercialization.

  • SBIR Phase II awards normally will be made for a 24-month period of performance.

  • Eligible prote´ge´s include certified small disadvantaged business concerns, women- owned small business concerns, veteran- owned or service-disabled veteran-owned small business concerns, HUBZone small business concerns, Historically Black Col- leges and Universities, minority institutions of higher education, as defined in FAR part 2, Definitions of Parts and Terms, active NASA SBIR Phase II companies and non- profit agencies employing the blind or se- verely handicapped as defined in 41 CFR chapter 51.

  • Successful transition of SBIR research and technology development into the commercial marketplace is difficult, and SBIR Phase II awardees often encounter significant challenges in navigating the regulatory approval process, raising capital, licensure and production, as they try to advance their projects towards commercialization.

  • All SBIR Phase II projects are required to conduct an out-briefing and provide a Phase II Impact Statement.

  • For SBIR Phase II, a minimum of one-half of the research or analytical effort must be performed by the Awardee.

  • This Agreement is a Small Business Innovation Research (SBIR) Phase II award.

Related to SBIR Phase II

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

  • Development Phase means the period before a vehicle type is type approved.

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Phase I means the first part of the tuition incentive assistance program defined as the academic period of 80 semester or 120 term credits, or less, leading to an associate degree or certificate.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Development Project means a project for the development of land within a

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Construction Phase Services means the coordination, implementation and execution of the Work required by this Agreement, which are further defined in Article 8.

  • Phase 2 means the second implementation phase of this section, beginning June 1, 2022 and continuing thereafter.

  • Construction Phase means that Phase of the Project which shall commence after the Authority provides the Trade Contractor with written Notice to Proceed with the Construction Phase.

  • Redevelopment project means a specific construction project

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Design Phase means the period during which the Transporter shall prepare a draft project proposal for publication in accordance with section 4.3;

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Redevelopment Project Area means an area designated by the municipality, which is not less in the aggregate than 1 1/2 acres and in respect to which the municipality has made a finding that there exist conditions which cause the area to be classified as an industrial park conservation area or a blighted area or a conservation area, or a combination of both blighted areas and conservation areas.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Project area budget means a multiyear projection of annual or cumulative

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.